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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREW Registered Establishment Name: BIO-PROT, S.A.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: INTRAMEDULLARY ROD Proprietary Device Name: SUPRACARDY ROD Registered Establishment Name: BIO-PROT, S.A.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: SMOOTH PIN Proprietary Device Name: VARIOUS TYPES Registered Establishment Name: BIO-PROT, S.A.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: THREADED PINS Proprietary Device Name: VARIOUS TYPES Registered Establishment Name: BIO-PROT, S.A.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: CERCLAGE, FIXATION Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: DISPENSER, CEMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: BONE CEMENT Generic Device Name: BONE CEMENT Proprietary Device Name: SURGICAL SIMPLEX P BONE CEMENT Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: CEMENT OBTURATOR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEES Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEES Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: VARIOUS TYPES OF HIPS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: VARIOUS TYPES OF HIPS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: CEMENT, BONE, VERTEBROPLASTY Generic Device Name: PMMA BONE CEMENT Proprietary Device Name: SPINEPLEX RADIOPAQUE BONE CEMENT Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: KNEE Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: CALCIUM SULFATE PELLETS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: PATELLO/FEMORAL KNEE Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: RADIAL HEAD Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: HUMERAL STEMS/HEADS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: ARTIFICIAL HIP COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: VARIOUS HIP IMPLANTS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER Generic Device Name: PRESS-FIT,UNCEMENTED KNEE Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: TEMPLATE Generic Device Name: TEMPLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: CAST REMOVAL AID Proprietary Device Name: ZIP STICK, CAST REMOVAL AID Registered Establishment Name: W.L. GORE & ASSOCIATES,INC. |
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Classification: STARTER, BONE SCREW Generic Device Name: BONE SCREW Proprietary Device Name: BONE SCREW Registered Establishment Name: W.L. GORE & ASSOCIATES,INC. |
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Classification: COMPONENT, CAST Generic Device Name: CAST LINER Proprietary Device Name: GORE-TEX PANTALOON Registered Establishment Name: W.L. GORE & ASSOCIATES,INC. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: GORE SMOOTHER CRUCIAL TOOL Proprietary Device Name: GORE SMOOTHER CRUCIAL TOOL Registered Establishment Name: W.L. GORE & ASSOCIATES,INC. |
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Classification: DYNAMOMETER, NONPOWERED Generic Device Name: BULB DYNAMOMETER Registered Establishment Name: CHRISTY MANUFACTURING CORP.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: GENERAL SURGICAL INSTRUMENT Registered Establishment Name: P.A.K. ORTHOPAEDICS. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: AIR OPERATED INSTRUMENT Registered Establishment Name: P.A.K. ORTHOPAEDICS. |
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Classification: EXTRACTOR Generic Device Name: SURGICAL STAPLE EXTRACTOR, LAPAROSCOPIC Proprietary Device Name: EXTRACTOR Registered Establishment Name: DESIGN STANDARDS CORP.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: INSTRUMED (PVT)LTD. Registered Establishment Name: INSTRUMED (PVT) LTD.. |
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Classification: AWL Generic Device Name: VARIOUS SIZES OF AWLS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDICAL PRECISION SPECIALITIES. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: CYGNUS TECHNOLOGIES, LLC.. |
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